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GUM Technique Sensitive Clean 527

by Sunstar Americas, Inc. 3 variants

GUM Technique Sensitive Clean 527 (TRA2) is a Class I device made by Sunstar Americas, Inc., listed in FDA GUDID since 15 Aug 2025 (UDI-DI 00070942007412), registry data as of 23 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00070942007412 UDI-DI Date15 Aug 2025ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name
GUM Technique Sensitive Clean
Generic name
Basic manual toothbrush
Model / Ref / Catalog
527, TRA2
Primary DI / UDI-DI
00070942007412
FDA product code
EFW
GMDN term
Basic manual toothbrush
Device class
Class I
Regulation number
872.6855
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code EFW (Toothbrush, Manual).

Other devices from Sunstar Americas, Inc.

See all devices from Sunstar Americas, Inc. →

Properties

Other properties (15, all answered No)